Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Pregnant participants were enrolled at 6 sites: United States (2), South Africa (3), and Puerto Rico (1).

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Of the 69 enrolled participants, 28 mothers were not treated. Failure to continue to meet enrollment criteria resulting in discontinuation in 24/28 participants and 4 were not treated: 1 poor/no compliance, 1 met exclusion criteria, 1 was ARV naive subject with HIV RNA < 400 c/mL, and 1 was unable to comply with study procedures.

Reporting Groups

Description

Mother ATV 300 mg / RTV 100 mg

Mothers receiving atazanavir (ATV) / ritonavir (RTV) 300/100 mg once daily (QD) + lamivudine (ZDV) / zidovudine (3TC) 300/150 mg twice daily (BID) during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Mother ATV 400 mg / RTV 100 mg

Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Infants ATV 300 mg / RTV 100 mg

Infants born to mothers receiving treatment with ATV 300 mg / RTV 100 mg during the third trimester of pregnancy.

Infants ATV 400 mg / RTV 100 mg

Infants born to mothers receiving treatment with ATV 400 mg / RTV 100 mg during the third trimester of pregnancy.

Participant Flow for 2 periods

Period 1: Pre-Natal Mothers

Mother ATV 300 mg / RTV 100 mg

Mother ATV 400 mg / RTV 100 mg

Infants ATV 300 mg / RTV 100 mg

Infants ATV 400 mg / RTV 100 mg

STARTED

20

21

0

0

COMPLETED

19
[1]

19
[1]

0
[2]

0
[2]

NOT COMPLETED

1

2

0

0

Discontinued ATV Before Delivery

1

2

0

0

[1]

Completion was defined as completing the study.

[2]

Completion was defined as completing all follow up visits through 6 months.

Period 2: Infants

Mother ATV 300 mg / RTV 100 mg

Mother ATV 400 mg / RTV 100 mg

Infants ATV 300 mg / RTV 100 mg

Infants ATV 400 mg / RTV 100 mg

STARTED

0

0

20
[1]

20
[2]

COMPLETED

0

0

20

20

NOT COMPLETED

0

0

0

0

[1]

All infants were followed.

[2]

All infants were followed. One mother withdrew consent pre-delivery and her infant was not followed.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Mother ATV 300 mg / RTV 100 mg

Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Mother ATV 400 mg / RTV 100 mg

Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Pregnancy Weeks 12 to 28, 28 to 36, and 4-6 Weeks Postpartum at 24 hours following the daily dose.

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Treated participants in the PK concentration data set.

Reporting Groups

Description

Mothers ATV 300 mg / RTV 100 mg Second Trimester

Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Mothers ATV 300 mg / RTV 100 mg Third Trimester

Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.

Mothers ATV 400 mg / RTV 100 mg Third Trimester

Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.